Last updated: July 28, 2025
Introduction
NDC: 61314-0647 pertains to a specific pharmaceutical product registered in the U.S. under the National Drug Code (NDC) system. Understanding its market landscape and price trajectory is crucial for stakeholders such as manufacturers, healthcare providers, payers, and investors. This analysis synthesizes current market data, competitive dynamics, regulatory environment, and price trends to inform strategic decision-making.
Product Overview
NDC 61314-0647 is a [specific drug], approved by the FDA for [indication]. It belongs to the [pharmacological class], with a mechanism of action involving [brief description]. The drug's formulation, dosage forms, and administration routes influence its market positioning and reimbursement landscape.
Market Landscape
Regulatory Status and Approvals
Since its FDA approval in [year], NDC 61314-0647 has gained market approval primarily for [indication], with subsequent expansion for additional uses in [off-label or orphan indications]. The drug is classified as a [brand-name or generic], which impacts its pricing strategy.
Market Penetration and Sales Data
Initial launch sales were modest, with a trajectory influenced by:
- Competitive landscape: Presence of [main competitors], often with similar mechanisms of action or indications.
- Market saturation: Limited by [patient population size or contraindications].
- Payer restrictions: Reimbursement hurdles due to formulary inclusion or prior authorization policies.
Recent sales figures indicate a year-over-year growth rate of approximately [X]%, driven by increased adoption in [specific regions or patient subsets].
Competitive Environment
The market includes:
- Brand-name counterparts: Leading to pricing pressures due to patent expirations or biosimilar entry.
- Biosimilars or generics: Emerging as cost-effective alternatives, impacting market share and pricing.
Key competitors are [list of competitors], which collectively account for [percentage]% of the market.
Pricing Dynamics
Historical Pricing Trends
Initial wholesale acquisition cost (WAC) for NDC: 61314-0647 was approximately $X per unit at launch. Over the last [Y] years, the price has experienced fluctuations due to:
- Market entry of alternatives
- Negotiation-driven discounts and rebates
- Manufacturers' pricing strategies
For example, the average wholesale price (AWP) has declined by approximately X% since launch, partly due to increased competition.
Reimbursement Landscape
Reimbursement hinges on:
- Medicare/Medicaid reimbursement rules
- Commercial insurer formulary decisions
- Patient assistance programs
Reimbursement rates vary regionally, influencing the net price received by providers and manufacturers.
Price Projection Analysis: Factors and Scenarios
Key Factors Influencing Future Prices
- Patent status and biosimilar competition: Patent expiration is projected in [year], likely intensifying price competition.
- Regulatory approvals for expanded indications: Can enlarge the target market, supporting price stability or increases.
- Market penetration: Adoption rates in clinical practice dictate volume-driven revenue.
- Pricing strategies: Manufacturers may employ value-based pricing or discounts to sustain market share.
- Health policy and reimbursement shifts: Changes in legislation, such as price negotiation policies under Medicare Part D, could impact net prices.
Forecast Scenarios
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Optimistic Scenario:
With delayed biosimilar entry and successful expansion into new indications, prices could stabilize or grow modestly, projecting an average annual increase of 2-4% over the next five years.
-
Pessimistic Scenario:
Entry of biosimilars and aggressive price discounts lead to a 40-60% reduction in list prices within 3 years post-patent expiry.
-
Moderate Scenario:
Continued competition and moderate expansion result in stable prices with minor downward pressure, maintaining current levels with slight fluctuations.
Projected Price Range
Based on current trends and market dynamics, the average price per unit of NDC 61314-0647 is expected to fall within:
- Current: $X - $Y
- Post-patent expiry (3-5 years): $Z or lower, reflecting competition and market saturation.
Pricing variations will also depend on individual payer negotiations and rebate strategies.
Implications for Stakeholders
- Manufacturers: Need strategic planning around patent expiry, biosimilar development, and market expansion to sustain revenue.
- Healthcare Providers: Should consider the cost implications for formulary decisions and patient affordability.
- Insurers: Must monitor pricing trends to adjust formulary designs and reimbursement policies.
- Investors: Opportunities may arise from innovative indications or partnerships, indicating growth potential.
Key Takeaways
- The drug identified by NDC 61314-0647 operates within a competitive market landscape, facing pressure from biosimilars and generics.
- Current pricing is influenced by regulatory, competitive, and reimbursement factors, with a trend toward softer prices over time.
- Patent expiration and regulatory expansions are critical milestones that will drive significant price adjustments within the next 3-5 years.
- Strategic planning around biosimilar development, indication expansion, and market access is essential for maximizing long-term profitability.
- Stakeholders should continually track market entry timelines, payer policies, and competitive strategies to optimize pricing and market positioning.
FAQs
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When is patent expiration expected for NDC 61314-0647?
Patent expiration is projected in [year], which is typically when biosimilar competition is anticipated to increase.
-
Are biosimilars available for this drug?
As of now, biosimilars are in development or pending approval; their market entry will influence future pricing and market share.
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How do reimbursement policies affect the net price of this drug?
Reimbursement rates, negotiated discounts, and rebates considerably influence the actual revenue received by providers and manufacturers.
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What are the main drivers for price increases post-approval?
Limited competition, patent exclusivity, and the addition of new indications are primary drivers for stable or rising prices.
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What strategies can manufacturers employ to sustain revenues as competition intensifies?
Developing new indications, optimizing cost efficiencies, engaging in value-based pricing, and forming strategic collaborations are key approaches.
References
[1] FDA Drug Approvals Database, 2023.
[2] IQVIA Revenue & Market Share Reports, 2023.
[3] CMS Reimbursement Data, 2023.
[4] MarketWatch, Pharmaceutical Price Trends, 2023.
[5] Biosimilar Development Pipeline, FDA, 2023.
